Senior Manager, Regulatory Affairs

Job Details

Make a meaningful regulatory impact

At Cencora, we are united in our responsibility to create healthier futures. We support clients to navigate complex regulatory pathways for health products including prescription and non-prescription drugs (small molecule and biologics), medical devices, natural health products (NHPs), and cosmetics so that important therapies can reach the people who need them.

We are seeking an experienced Senior Manager, Regulatory Affairs with a clinical focus to provide strategic, client-facing regulatory consulting across the health product lifecycle. In this role, you will lead complex regulatory projects, shape practical regulatory strategies, and act as a trusted partner to clients, Regulatory Authorities (Health Canada and U.S. FDA) and cross-functional colleagues.

This is an opportunity for a regulatory professional who combines technical knowledge with sound commercial judgement, confident client leadership and a practical approach to solving complex problems.

What you'll do

As Senior Manager, Regulatory Affairs, you will:

• Lead and manage regulatory strategy and consulting engagements for life sciences clients.
• Direct the planning, preparation, review and maintenance of regulatory submissions and associated documentation, including as applicable:
  • Clinical Trial Applications (CTAs)
  • Investigational New Drug applications (INDs)
  • New Drug Submissions (NDSs)
  • New Drug Applications (NDAs) and supplements
  • Product Licence Applications (PLAs)
  • DIN Submissions
  • Regulatory responses, amendments and post-approval activities
• Lead due diligence reviews
• Develop product labeling
• Support product launch planning and advertising/promotional material review
• Serve as a principal point of contact for assigned clients and support productive interactions with Regulatory Authorities.
• Lead or support agency meetings, develop briefing materials and provide strategic recommendations on emerging regulatory issues.
• Partner with cross-functional teams to integrate regulatory strategy with development, quality, clinical, medical, commercial and business objectives.
• Interpret evolving regulatory requirements and translate regulatory intelligence into clear, actionable guidance for clients and internal stakeholders.
• Manage multiple projects to agreed scope, timelines, budgets and quality expectations.
• Identify and resolve regulatory risks, issues and competing priorities using sound judgement and a solutions-focused approach.
• Ensure deliverables meet applicable client requirements, standard operating procedures and quality expectations, while identifying opportunities for continuous improvement.
• Contribute to the growth of the practice by supporting proposals, presentations, new-business discussions and development of client relationships.
• Share expertise through internal training, mentoring, industry presentations, publications or webinars.
• Manages decision-making and conflict resolution surrounding regulatory issues for assigned projects and within their team
• Participate in professional activities such as offering industry training, conference presentations, publications and webinars as applicable
• Engage in continuous learning in order to provide effective consulting services and train/coach colleagues.
• Other duties as assigned

#LI-AT2

What you'll bring

Required qualifications and experience

• Bachelor's degree in a life-sciences discipline; an advanced degree in a relevant scientific or regulatory field is preferred.
• 5-8 years of direct regulatory affairs experience across the health product lifecycle
• Clinical research or regulatory consulting experience preferred
• Demonstrated experience developing pre-market submissions and managing product lifecycle submissions/post-market changes
• Strong working knowledge of Canadian regulatory requirements and Health Canada processes, with familiarity with relevant ICH requirements. Experience with FDA, EMA and other international regulatory environments is an asset.
• Experience managing or supporting interactions with Regulatory Authorities.
• Proven ability to lead several concurrent client projects while managing timelines, scope, quality and budget considerations.
• Strong strategic thinking, analytical judgement and problem-solving capability.
• Excellent written, verbal and presentation skills, with the ability to explain complex regulatory issues clearly to varied audiences.
• Demonstrated ability to build trusted relationships with clients and collaborate effectively in multidisciplinary teams.
• Strong business acumen and an interest in contributing to proposals, client development and practice growth.
• French-English bilingualism preferred, written and spoken.
• Regulatory Affairs Certification (RAC) and prior people-leadership or consulting experience are assets.

What will help you succeed

You will thrive in this role if you are someone who:

• Enjoys translating complex regulatory requirements into practical paths forward.
• Balances scientific and regulatory rigour with client, patient and business needs.
• Is comfortable taking ownership of client relationships and senior-level conversations.
• Brings calm, structure and sound judgement to ambiguous or time-sensitive regulatory challenges.
• Is motivated by continuous learning and sharing expertise with colleagues and clients.

Why join Cencora?

You will join a purpose-driven organisation working to create healthier futures. In this role, you will have the opportunity to:

• Influence regulatory strategy on a diverse range of client and product-development challenges.
• Work with experienced regulatory, scientific and commercial colleagues in a collaborative environment.
• Build your consulting, leadership and business-development capability alongside your regulatory expertise.
• Contribute to work that supports access to therapies and healthcare products.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Salary Range*

$119,100 CAD - 186,560 CAD

This posting is intended to fill an existing vacancy for our Senior Manager, Regulatory Affairs role.

Affiliated Companies:
Affiliated Companies: Innomar Strategies